Secondary Prevention, Stroke, Ischemic Heart Disease, Coronary Heart Disease
Conditions
Keywords
Low-dose Acetylsalicylic Acid,, Bleeding,, The Health Improvement Network (THIN),, Cardiovascular, Secondary prevention of cardiovascular events
Brief summary
To investigate the risk of major bleeding (including gastrointestinal and intracranial bleeding episodes) among new users of low-dose acetylsalicylic acid (ASA) in clinical practice
Detailed description
These will be based on population-based cohorts using data from a primary care database in the UK: The Health Improvement Network (THIN) and will serve to make a clinically meaningful benefit-risk assessment regarding major bleeding consequences of ASA exposure in general population.
Interventions
Low-dose ASA for secondary prevention of cardiovascular events
DRUGClopidogrel, Oral Anticoagulants, NSAIDs and SSRIs
Secondary prevention of cardiovascular events
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 84 Years
Healthy volunteers
No
Inclusion criteria
* Aged 40-84 years * Enrolled with the Primary Care Physician (PCP) for at least 2 years, * To have a history of computerized prescriptions for at least 1 year prior * To have at least one encounter/visit recorded in the last three years
Exclusion criteria
* To be exposed to low dose ASA before entering in the study * Having a diagnosis of cancer before entering in the study * Having a diagnosis of alcohol abuse before entering in the study * Having a diagnosis of coagulopathies before entering in the study * Having a diagnosis of esophageal varices before entering in the study * Having a diagnosis of chronic liver disease before entering in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative risk of Lower gastrointestinal bleeding among new users of low-dose ASA | Up to 13 years | Relative risk is calculated as incident rate ratio produced by dividing the incidence rate of the outcome of interest in the exposed category by the incidence rate of the outcome of interest in the unexposed. |
| Time to Lower gastrointestinal bleeding among new users of low-dose ASA | Up to 13 years | — |
| Relative risk of Intracranial bleeding among new users of low dose ASA | Up to 13 years | Relative risk is calculated as incident rate ratio produced by dividing the incidence rate of the outcome of interest in the exposed category by the incidence rate of the outcome of interest in the unexposed. |
| Relative risk of Upper gastrointestinal bleeding among new users of low-dose ASA | Up to 13 years | Relative risk is calculated as incident rate ratio produced by dividing the incidence rate of the outcome of interest in the exposed category by the incidence rate of the outcome of interest in the unexposed. |
| Incidence of Intracranial bleeding among new users of low-dose Acetylsalicylic acid (ASA). | Up to 13 years | — |
| Incidence of Upper gastrointestinal bleeding among new users of low-dose ASA. | Up to 13 years | — |
| Incidence of Lower gastrointestinal bleeding among new users of low-dose ASA | Up to 13 years | — |
| Time to Intracranial bleeding among new users of low-dose ASA | Up to 13 years | — |
| Time to Upper gastrointestinal bleeding among new users of low-dose ASA | Up to 13 years | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative risk of Upper gastrointestinal bleeding associated with use of other medications | Up to 13 years | Relative risk is calculated as incident rate ratio produced by dividing the incidence rate of the outcome of interest in the exposed category by the incidence rate of the outcome of interest in the unexposed.To estimate relative risk in users of other medications such as clopidogrel,oral anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDs) and selective serotonin reuptake inhibitors (SSRIs), independently from use of low-dose ASA and concomitantly |
| Relative risk of Lower gastrointestinal bleeding associated with use of other medications. | Up to 13 years | Relative risk is calculated as incident rate ratio produced by dividing the incidence rate of the outcome of interest in the exposed category by the incidence rate of the outcome of interest in the unexposed.To estimate relative risk in users of other medications such as clopidogrel,oral anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDs) and selective serotonin reuptake inhibitors (SSRIs), independently from use of low-dose ASA and concomitantly |
| Relative risk of Intracranial bleeding associated with use of other medications. | Up to 13 years | Relative risk is calculated as incident rate ratio produced by dividing the incidence rate of the outcome of interest in the exposed category by the incidence rate of the outcome of interest in the unexposed.To estimate relative risk in users of other medications such as clopidogrel,oral anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDs) and selective serotonin reuptake inhibitors (SSRIs), independently from use of low-dose ASA and concomitantly |
Countries
United Kingdom
Outcome results
None listed